Trial Outcomes & Findings for Molecular Transducers of Physical Activity Consortium (NCT NCT03960827)

NCT ID: NCT03960827

Last Updated: 2026-07-15

Results Overview

Changes in log-transformed CPET VO2 Peak calculated as L/min

Recruitment status

COMPLETED

Study phase

Target enrollment

1836 participants

Primary outcome timeframe

Baseline; Week 12

Results posted on

2026-07-15

Participant Flow

Recruitment was completed across 11 U.S. sites between August 2019 and January 2025. Participants were randomized to EE, RE, or CON or enrolled to HAEE or HARE.

Participants were pre-screened on the phone and then brought in for consent and additional screening which included physical activity assessments prior to randomization or enrollment to groups.

Participant milestones

Participant milestones
Measure	Sedentary EE Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.	Highly Active EE A comparison group of highly active EE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants were tested on a cycle ergometer.	Highly Active RE A comparison group of highly active RE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants were tested via a bout of resistance exercise.
Overall Study STARTED	652	641	248	133	162
Overall Study COMPLETED	551	555	213	125	154
Overall Study NOT COMPLETED	101	86	35	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Sedentary EE Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.	Highly Active EE A comparison group of highly active EE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants were tested on a cycle ergometer.	Highly Active RE A comparison group of highly active RE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants were tested via a bout of resistance exercise.
Overall Study Lost to Follow-up	30	25	10	1	3
Overall Study Pregnancy	0	0	1	0	0
Overall Study Adverse Event	7	5	2	0	1
Overall Study Physician Decision	3	5	0	0	0
Overall Study Other	1	1	0	1	1
Overall Study Suspension due to COVID-19	0	0	0	1	2
Overall Study Withdrawal by Subject	60	50	22	5	1

Baseline Characteristics

Unable to obtain the baseline measurement due to machine failure or other technical issue.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.	Highly Active EE n=133 Participants A comparison group of highly active EE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants were tested on a cycle ergometer.	Highly Active RE n=162 Participants A comparison group of highly active RE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants were tested via a bout of resistance exercise.	Total n=1836 Participants Total of all reporting groups
Age, Continuous	46 Years STANDARD_DEVIATION 15 • n=652 Participants	45 Years STANDARD_DEVIATION 15 • n=641 Participants	45 Years STANDARD_DEVIATION 14 • n=248 Participants	49 Years STANDARD_DEVIATION 15 • n=133 Participants	39 Years STANDARD_DEVIATION 14 • n=162 Participants	45 Years STANDARD_DEVIATION 15 • n=1836 Participants
Age, Customized Age, group · 18-39 years	252 Participants n=652 Participants	257 Participants n=641 Participants	89 Participants n=248 Participants	42 Participants n=133 Participants	96 Participants n=162 Participants	736 Participants n=1836 Participants
Age, Customized Age, group · 40-59 years	260 Participants n=652 Participants	254 Participants n=641 Participants	107 Participants n=248 Participants	57 Participants n=133 Participants	45 Participants n=162 Participants	723 Participants n=1836 Participants
Age, Customized Age, group · 60+ years	140 Participants n=652 Participants	130 Participants n=641 Participants	52 Participants n=248 Participants	34 Participants n=133 Participants	21 Participants n=162 Participants	377 Participants n=1836 Participants
Sex: Female, Male Female	449 Participants n=652 Participants	445 Participants n=641 Participants	156 Participants n=248 Participants	50 Participants n=133 Participants	71 Participants n=162 Participants	1171 Participants n=1836 Participants
Sex: Female, Male Male	203 Participants n=652 Participants	196 Participants n=641 Participants	92 Participants n=248 Participants	83 Participants n=133 Participants	91 Participants n=162 Participants	665 Participants n=1836 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=652 Participants	2 Participants n=641 Participants	0 Participants n=248 Participants	0 Participants n=133 Participants	0 Participants n=162 Participants	4 Participants n=1836 Participants
Race (NIH/OMB) Asian	65 Participants n=652 Participants	55 Participants n=641 Participants	16 Participants n=248 Participants	5 Participants n=133 Participants	8 Participants n=162 Participants	149 Participants n=1836 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=652 Participants	2 Participants n=641 Participants	0 Participants n=248 Participants	1 Participants n=133 Participants	0 Participants n=162 Participants	3 Participants n=1836 Participants
Race (NIH/OMB) Black or African American	83 Participants n=652 Participants	90 Participants n=641 Participants	31 Participants n=248 Participants	4 Participants n=133 Participants	25 Participants n=162 Participants	233 Participants n=1836 Participants
Race (NIH/OMB) White	451 Participants n=652 Participants	448 Participants n=641 Participants	179 Participants n=248 Participants	119 Participants n=133 Participants	113 Participants n=162 Participants	1310 Participants n=1836 Participants
Race (NIH/OMB) More than one race	27 Participants n=652 Participants	18 Participants n=641 Participants	10 Participants n=248 Participants	1 Participants n=133 Participants	4 Participants n=162 Participants	60 Participants n=1836 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=652 Participants	26 Participants n=641 Participants	12 Participants n=248 Participants	3 Participants n=133 Participants	12 Participants n=162 Participants	77 Participants n=1836 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	137 Participants n=652 Participants	127 Participants n=641 Participants	60 Participants n=248 Participants	18 Participants n=133 Participants	30 Participants n=162 Participants	372 Participants n=1836 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	514 Participants n=652 Participants	513 Participants n=641 Participants	188 Participants n=248 Participants	115 Participants n=133 Participants	131 Participants n=162 Participants	1461 Participants n=1836 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=652 Participants	1 Participants n=641 Participants	0 Participants n=248 Participants	0 Participants n=133 Participants	1 Participants n=162 Participants	3 Participants n=1836 Participants
High-Density Lipoprotein Cholesterol (HDL-C)	58 mg/dl STANDARD_DEVIATION 16 • n=652 Participants	59 mg/dl STANDARD_DEVIATION 16 • n=641 Participants	59 mg/dl STANDARD_DEVIATION 17 • n=248 Participants	65 mg/dl STANDARD_DEVIATION 18 • n=133 Participants	60 mg/dl STANDARD_DEVIATION 15 • n=162 Participants	59 mg/dl STANDARD_DEVIATION 16 • n=1836 Participants
Low-Density Lipoprotein Cholesterol (LDL-C)	113 mg/dl STANDARD_DEVIATION 31 • n=652 Participants	114 mg/dl STANDARD_DEVIATION 31 • n=641 Participants	112 mg/dl STANDARD_DEVIATION 29 • n=248 Participants	110 mg/dl STANDARD_DEVIATION 29 • n=133 Participants	105 mg/dl STANDARD_DEVIATION 33 • n=162 Participants	112 mg/dl STANDARD_DEVIATION 31 • n=1836 Participants
Triglycerides	104 mg/dl STANDARD_DEVIATION 52 • n=652 Participants	104 mg/dl STANDARD_DEVIATION 55 • n=641 Participants	108 mg/dl STANDARD_DEVIATION 62 • n=248 Participants	76 mg/dl STANDARD_DEVIATION 39 • n=133 Participants	81 mg/dl STANDARD_DEVIATION 41 • n=162 Participants	100 mg/dl STANDARD_DEVIATION 53 • n=1836 Participants
Hemoglobin A1c (HbA1c)	5.4 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.4 • n=652 Participants	5.4 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.4 • n=641 Participants	5.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.4 • n=248 Participants	5.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.3 • n=133 Participants	5.2 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.3 • n=162 Participants	5.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.4 • n=1836 Participants
Screening Height	167.4 cm STANDARD_DEVIATION 78.5 • n=652 Participants	167.3 cm STANDARD_DEVIATION 9.3 • n=641 Participants	169.1 cm STANDARD_DEVIATION 9.7 • n=248 Participants	173.5 cm STANDARD_DEVIATION 10.1 • n=133 Participants	170.3 cm STANDARD_DEVIATION 9.6 • n=162 Participants	168.3 cm STANDARD_DEVIATION 9.8 • n=1836 Participants
Screening Weight	78.5 kg STANDARD_DEVIATION 15.6 • n=652 Participants	78.1 kg STANDARD_DEVIATION 15.2 • n=641 Participants	79.9 kg STANDARD_DEVIATION 15.4 • n=248 Participants	73.9 kg STANDARD_DEVIATION 13.2 • n=133 Participants	76.5 kg STANDARD_DEVIATION 13.3 • n=162 Participants	78.0 kg STANDARD_DEVIATION 15.1 • n=1836 Participants
Body Mass Index (BMI)	27.9 kg/m^2 STANDARD_DEVIATION 4.2 • n=652 Participants	27.8 kg/m^2 STANDARD_DEVIATION 4.3 • n=641 Participants	27.9 kg/m^2 STANDARD_DEVIATION 4.3 • n=248 Participants	24.4 kg/m^2 STANDARD_DEVIATION 3.2 • n=133 Participants	26.3 kg/m^2 STANDARD_DEVIATION 3.2 • n=162 Participants	27.4 kg/m^2 STANDARD_DEVIATION 4.2 • n=1836 Participants
Absolute VO2 Peak	1.73 L/min STANDARD_DEVIATION 0.56 • n=652 Participants	1.74 L/min STANDARD_DEVIATION 0.58 • n=641 Participants	1.82 L/min STANDARD_DEVIATION 0.55 • n=248 Participants	3.08 L/min STANDARD_DEVIATION 1.01 • n=133 Participants	2.54 L/min STANDARD_DEVIATION 0.70 • n=162 Participants	1.92 L/min STANDARD_DEVIATION 0.74 • n=1836 Participants
Relative VO2 Peak	22.0 ml/kg/min STANDARD_DEVIATION 5.7 • n=652 Participants	22.4 ml/kg/min STANDARD_DEVIATION 5.9 • n=641 Participants	23.0 ml/kg/min STANDARD_DEVIATION 5.8 • n=248 Participants	41.7 ml/kg/min STANDARD_DEVIATION 11.7 • n=133 Participants	33.5 ml/kg/min STANDARD_DEVIATION 7.7 • n=162 Participants	24.7 ml/kg/min STANDARD_DEVIATION 8.7 • n=1836 Participants
Knee Extensor Strength	146.8 Newton meters STANDARD_DEVIATION 55.9 • n=652 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.	150.8 Newton meters STANDARD_DEVIATION 56.7 • n=640 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.	154.8 Newton meters STANDARD_DEVIATION 59.0 • n=247 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.	187.0 Newton meters STANDARD_DEVIATION 75.9 • n=130 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.	202.5 Newton meters STANDARD_DEVIATION 74.8 • n=153 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.	156.9 Newton meters STANDARD_DEVIATION 62.3 • n=1822 Participants • Unable to obtain the baseline measurement due to machine failure or other technical issue.

PRIMARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups were recruited only for a baseline comparison and do not have any outcomes.

Changes in log-transformed CPET VO2 Peak calculated as L/min

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
Cardiopulmonary Exercise Test (CPET) VO2 Peak	1.14 ratio of geometric means Interval 1.12 to 1.15	1.08 ratio of geometric means Interval 1.07 to 1.09	0.97 ratio of geometric means Interval 0.95 to 0.99

PRIMARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups do not have outcomes. One participant in Control had a coefficient of variation \> 10 after multiple trials at baseline which was outside the prespecified inclusion for analysis and had no follow-up measure. One participant in Sedentary RE did not have a peak torque measurement at either baseline or follow-up.

Changes in log-transformed knee extensor strength measured in newton meters

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=640 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=247 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
Knee Extensor Strength	1.01 ratio of geometric means Interval 0.99 to 1.02	1.10 ratio of geometric means Interval 1.08 to 1.12	1.00 ratio of geometric means Interval 0.98 to 1.02

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups do not have outcomes.

Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
High-Density Lipoprotein Cholesterol (HDL-C)	0.98 ratio of geometric means Interval 0.97 to 0.99	0.98 ratio of geometric means Interval 0.97 to 0.99	0.97 ratio of geometric means Interval 0.95 to 0.99

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups do not have outcomes.

Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
Low-Density Lipoprotein Cholesterol (LDL-C)	-4.64 absolute difference in mg/dL Interval -6.29 to -3.0	-4.02 absolute difference in mg/dL Interval -5.64 to -2.4	-2.93 absolute difference in mg/dL Interval -5.54 to -0.33

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups do not have outcomes.

Changes in log-transformed Triglycerides (mg/dL)

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
Triglycerides	0.97 ratio of geometric means Interval 0.95 to 1.0	0.99 ratio of geometric means Interval 0.97 to 1.02	0.97 ratio of geometric means Interval 0.93 to 1.02

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Only the randomized Sedentary EE, Sedentary RE, and Sedentary Control participants were included in the analyses. Highly Active EE and Highly Active RE groups do not have outcomes.

Changes in Hemoglobin (HbA1c) (%)

Outcome measures

Outcome measures
Measure	Sedentary EE n=652 Participants Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 Participants Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 Participants The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.
Hemoglobin A1c (HbA1c)	0.03 absolute difference in % Interval 0.01 to 0.04	0.02 absolute difference in % Interval 0.01 to 0.04	0.05 absolute difference in % Interval 0.02 to 0.08

Adverse Events

Sedentary EE

Serious events: 2 serious events

Other events: 543 other events

Deaths: 0 deaths

Sedentary RE

Serious events: 5 serious events

Other events: 559 other events

Deaths: 0 deaths

Sedentary Control

Serious events: 1 serious events

Other events: 174 other events

Deaths: 0 deaths

Highly Active EE

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Highly Active RE

Serious events: 0 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sedentary EE n=652 participants at risk Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 participants at risk Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 participants at risk The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.	Highly Active EE n=133 participants at risk A comparison group of highly active EE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants were tested on a cycle ergometer.	Highly Active RE n=162 participants at risk A comparison group of highly active RE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants were tested via a bout of resistance exercise.
Cardiac disorders Chest pain - cardiac	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Psychiatric disorders Depression	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Headache	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Acute kidney injury	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.

Other adverse events

Other adverse events
Measure	Sedentary EE n=652 participants at risk Participants randomized to EE first engaged in a single acute exercise test of Endurance Exercise (on a cycle ergometer) consistent with their random assignment.	Sedentary RE n=641 participants at risk Participants randomized to RE first engaged in a single acute exercise test of Resistance Exercise, consistent with their random assignment.	Sedentary Control n=248 participants at risk The control group did not engage in any acute exercise testing protocol, but biospecimens were collected prior to and following a period of rest.	Highly Active EE n=133 participants at risk A comparison group of highly active EE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants were tested on a cycle ergometer.	Highly Active RE n=162 participants at risk A comparison group of highly active RE participants were recruited and engaged only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants were tested via a bout of resistance exercise.
Blood and lymphatic system disorders Anemia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Blood and lymphatic system disorders Leukocytosis	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Atrial fibrillation	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Cardiac disorders - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Chest pain - cardiac	0.61% 4/652 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Palpitations	1.5% 10/652 • Number of events 12 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 4/641 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Ear pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Hearing impaired	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Tinnitus	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Ear and labyrinth disorders Vertigo	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Endocrine disorders Endocrine disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.81% 2/248 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Endocrine disorders Hypothyroidism	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Eye disorders Eye disorders - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Eye disorders Retinal tear	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Abdominal pain	0.46% 3/652 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Constipation	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Diarrhea	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Esophagitis	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Gastric ulcer	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Gastritis	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Gastroesophageal reflux disease	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Hemorrhoids	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Nausea	14.3% 93/652 • Number of events 125 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	17.3% 111/641 • Number of events 151 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	5.6% 14/248 • Number of events 16 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	11.7% 19/162 • Number of events 21 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Stomach pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Toothache	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Vomiting	2.3% 15/652 • Number of events 17 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.9% 25/641 • Number of events 33 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	2.5% 4/162 • Number of events 5 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Fatigue	29.3% 191/652 • Number of events 347 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	34.3% 220/641 • Number of events 436 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	10.9% 27/248 • Number of events 36 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.5% 2/133 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	9.9% 16/162 • Number of events 17 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Flu like symptoms	4.1% 27/652 • Number of events 29 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.9% 12/641 • Number of events 12 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders General disorders and administration site conditions - Other	0.61% 4/652 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Malaise	0.92% 6/652 • Number of events 7 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.78% 5/641 • Number of events 6 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Pain	32.8% 214/652 • Number of events 319 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	42.4% 272/641 • Number of events 456 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	35.5% 88/248 • Number of events 131 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	21.8% 29/133 • Number of events 41 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	37.7% 61/162 • Number of events 92 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Hepatobiliary disorders Gallbladder pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Hepatobiliary disorders Hepatobiliary disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Immune system disorders Allergic reaction	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Bronchial infection	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Conjunctivitis	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Eye infection	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Infections and infestations - Other	0.46% 3/652 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Lung infection	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Otitis media	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Pharyngitis	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Phlebitis infective	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Sinusitis	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Tooth infection	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Upper respiratory infection	6.0% 39/652 • Number of events 40 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	6.4% 41/641 • Number of events 42 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Urinary tract infection	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Vaginal infection	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Vulval infection	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Wound infection	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Bruising	29.9% 195/652 • Number of events 247 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	27.1% 174/641 • Number of events 224 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	34.3% 85/248 • Number of events 110 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	9.0% 12/133 • Number of events 13 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	12.3% 20/162 • Number of events 25 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Burn	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Fall	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Fracture	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations Blood bicarbonate decreased	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations Investigations - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations Lymphocyte count decreased	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations Neutrophil count decreased	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations Thyroid stimulating hormone increased	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Investigations White blood cell decreased	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Hyperlipidemia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Hypocalcemia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Hypokalemia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Arthralgia	24.5% 160/652 • Number of events 285 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	42.6% 273/641 • Number of events 908 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	8.9% 22/248 • Number of events 30 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	6.8% 11/162 • Number of events 14 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Arthritis	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Back pain	1.1% 7/652 • Number of events 7 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.6% 10/641 • Number of events 11 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Buttock pain	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Flank pain	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Myalgia	31.3% 204/652 • Number of events 468 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	49.3% 316/641 • Number of events 811 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	13.7% 34/248 • Number of events 42 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	12.3% 20/162 • Number of events 21 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 7/652 • Number of events 7 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.2% 8/641 • Number of events 9 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 1/162 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Rotator cuff injury	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Dizziness	14.4% 94/652 • Number of events 132 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	15.0% 96/641 • Number of events 125 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	10.9% 27/248 • Number of events 33 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	2.3% 3/133 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	4.9% 8/162 • Number of events 9 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Headache	1.1% 7/652 • Number of events 8 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.1% 20/641 • Number of events 22 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.81% 2/248 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Nervous system disorders - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Paresthesia	3.5% 23/652 • Number of events 23 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.0% 19/641 • Number of events 19 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.2% 8/248 • Number of events 8 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.5% 2/133 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 1/162 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Peripheral sensory neuropathy	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 1/162 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Presyncope	26.5% 173/652 • Number of events 280 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	31.5% 202/641 • Number of events 370 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	16.5% 41/248 • Number of events 56 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.0% 4/133 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	16.0% 26/162 • Number of events 32 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Vasovagal reaction	6.6% 43/652 • Number of events 51 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	8.0% 51/641 • Number of events 57 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	2.4% 6/248 • Number of events 6 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	2.5% 4/162 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Psychiatric disorders Anxiety	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Psychiatric disorders Depression	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.81% 2/248 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Psychiatric disorders Insomnia	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Acute kidney injury	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Hematuria	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Renal calculi	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Urinary frequency	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 1/162 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Urinary incontinence	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Urinary tract pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Reproductive system and breast disorders Pelvic pain	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Reproductive system and breast disorders Testicular pain	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.61% 4/652 • Number of events 5 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.31% 2/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Sneezing	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Sore throat	0.46% 3/652 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 4/641 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Pain of skin	17.6% 115/652 • Number of events 162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	19.8% 127/641 • Number of events 167 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	22.2% 55/248 • Number of events 67 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	2.3% 3/133 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	4.3% 7/162 • Number of events 9 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Urticaria	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.81% 2/248 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.2% 2/162 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.47% 3/641 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Vascular disorders Hematoma	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Vascular disorders Hypertension	0.61% 4/652 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Vascular disorders Hypotension	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Vascular disorders Vascular disorders - Other	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Sinus tachycardia	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Cardiac disorders Supraventricular tachycardia	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Eye disorders Blurred vision	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Dysphagia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Enterocolitis	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Gastrointestinal disorders Flatulence	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Edema limbs	6.7% 44/652 • Number of events 48 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	7.3% 47/641 • Number of events 50 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	6.9% 17/248 • Number of events 19 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.5% 2/133 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	1.2% 2/162 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
General disorders Fever	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Rhinitis infective	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Infections and infestations Skin infection	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Injury, poisoning and procedural complications Wound complication	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Dehydration	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Metabolism and nutrition disorders Hypoglycemia	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Bone pain	0.31% 2/652 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Muscle cramp	17.2% 112/652 • Number of events 187 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	19.2% 123/641 • Number of events 227 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	11.3% 28/248 • Number of events 42 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	4.9% 8/162 • Number of events 9 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Movements involuntary	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Syncope	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Nervous system disorders Tremor	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Renal and urinary disorders Dysuria	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.5% 36/652 • Number of events 47 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	3.4% 22/641 • Number of events 32 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	4.4% 11/248 • Number of events 14 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.75% 1/133 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.62% 1/162 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.15% 1/652 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/641 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/248 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/652 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.16% 1/641 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.40% 1/248 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/133 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.	0.00% 0/162 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for SED this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing). Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.

Additional Information

Michael Miller

Wake Forest University School of Medicine

Phone: 336-716-6837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place